• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 482812
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Laceration(s) (1946); Pain (1994); Scarring (2061); Tissue Damage (2104); Discharge (2225); Distress (2329); Discomfort (2330); Injury (2348); Prolapse (2475); Blood Loss (2597); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of vault prolapse, large cystocele and stress urinary incontinence. It was reported that after implant, the patient experienced blood loss, third degree cystocele, second degree rectocele (prolapse), second to third degree uterine prolapse, endometrial lesion, extensive scarring under the bladder (scarring), pelvic organ prolapse pelvic floor prolapse, continued urinary incontinence, continued/increased stress urinary incontinence, myomas x 2, hypermobile urethra, very thickened anterior vaginal wall due to the graft, uterine polyps, continuous pain, discomfort, drainage, mental and physical stress, vaginal vault damage, recurrence, infection, unspecified urinary problems, unspecified bowel problems, as well as unspecified neuromuscular problems. The device had been used with mentor ob/tape 93-4000 (lot# 040702e). Post-operative patient treatment included additional surgical interventions.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH TSL - PELVICOL¿
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key8768489
MDR Text Key150389102
Report Number9617613-2019-00117
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/01/2006
Device MODEL Number482812
Device Catalogue Number482812
Device LOT Number04B23-9
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/08/2019 Patient Sequence Number: 1
-
-